MMR vaccine and Development of Autism

What is the correlation between children who do not get the MMR vaccine and end up Developing Autism?
1. Describe/ explain in detail the purpose of the research and will it be qualitative or quantitative?
While a significant pool of research spanning the past fifteen years has failed to relate the measles-mumps-rubella (MMR) vaccine to ASD (autism spectrum disorder), parents as well as other entities continually associate the two. Parents refuse or postpone inoculating their children claiming that inoculation (in general) and the MMR shot (in particular) are ASD- causing factors. Decreased inoculation levels are a public health threat as they reduce individual as well as group immunity, besides being linked to numerous recent measles outbreaks, mostly in the non- inoculated population. Parents with ASD- diagnosed children are potentially especially concerned about the reported relationship between ASD and MMR, in spite of scant evidence indicating this association. Surveys of ASD- diagnosed children’s parents indicate that several of them hold the belief that MMR vaccination was a contributor. A recent autistic- child survey (486 participants) revealed that almost two in five had postponed or refused MMR inoculation among these children’s younger siblings. Moreover, a Canadian research (n=98) on autistic children’s younger siblings revealed younger siblings to be less likely to receive full MMR immunization in comparison to their older, autistic siblings. But statistically significant distinctions have yet to be found with regard to autism diagnosis rates between non- vaccinated and vaccinated children (Jain et al, 2015).
In spite of numerous epidemiological researches failing to connect the MMR shot to autism, the debate on its safety continues. Anti- inoculation websites and companies which portray themselves to be official resources on credible vaccine- related information continually provide prejudiced or unsound MMR- related information. This fuels public concerns pertaining to MMR’s safety, resulting in increased immunization postponement/ refusal rates thereby giving rise to significant risks of measles outbreaks in the US and several European nations. For countering such anti- immunization advocates and promoting increased vaccination acceptance in general, there is a need for evidence- based data on immunization’s risks and benefits. The theory that MMR, being a triple live shot, proves more harmful for the neurodevelopment of children when compared with single measles shots, had emerged previously as well. Still, researchers have failed to provide proofs against MMR vaccination. Though prior researches concentrated on autism and other more advanced ailments, present epidemiological researches seek subtler neurodevelopmental results associated, potentially, with vaccine exposure, which may be detected using psychological tests that are sensitive enough to identify even trivial, subclinical disorders among children. Including a broad array of likely confounders influencing child neurodevelopment, such as maternal age, prenatal lead and mercury exposure, maternal IQ and education, besides other pre- and post- natal elements is also crucial (Mrozek-Budzyn, Kie?tyka, Majewska & Augustyniak, 2013).
In the past few years, Poland presented a great opportunity of conducting MMR safety- related researches as the child population was diversified as regards measles vaccine history. A few infants were MMR- immunized voluntarily (by paying extra money) while some others received only single measles shots in accordance with the country’s mandatory immunization schedule until 2004. The remaining children were evidently not measles- inoculated for various reasons (Mrozek-Budzyn, Kie?tyka, Majewska & Augustyniak, 2013).
This quantitative research aims at examining the theory that exposure to MMR negatively impacts child cognitive development. Further, MMR vaccine exposure will be evaluated compared with single measles shot exposure for ascertaining the likely difference of their safety in terms of cognitive child development.
2. Research question – Explain/ describe the research question, what it will prove or bring to light?
Overwhelming scientific proofs reveal no association exists between autism and vaccines. A majority of individuals are bringing their children in for immunization according to schedule; however, the public risk is real despite only some children remaining unvaccinated. The anti- immunization movement was rendered entirely unreliable in the year 2005 after the total retraction of a Lancet paper initially suggesting a relationship between autism and vaccines when its results were discredited. Five years later, Andrew Wakefield, the anti- immunization drive’s figurehead and the aforementioned study’s main author was additionally accused of scientific misrepresentation, fraud, and ethical violation, with his practice license revoked in Britain (SABIN VACCINE INSTITUTE, 2017).
After Wakefield’s 1998 research, extensive scientific studies have debunked any relationships between autism and vaccines. In the year 2012, for instance, an examination of ten independent researches that involved over 1.26 million kids discovered no linkage between vaccines (especially MMR) and autism. The examination further revealed no linkage between thimerosal/ mercury and autism (thimerosal is a mercury- based preservative removed, in the year 2001, from child vaccines on account of now- invalidated concerns of its potential damaging effects in children. In the year 2015, a Japanese research once again failed to reveal any linkage between thimerosal/ MMR and autism in spite of increasing thimerosal dosages among some children because of receiving multiple shots over time. A second research conducted in the same year, involving over 95,000 children, also failed to establish a linkage between autism and MMR, even among children regarded as being highly prone to developing autism. Several hundred independent research works performed in the past fifteen years have concluded identically: vaccines are not an autism- causing factor. Considering this massive evidential pool, scientists concur that both vaccines and their ingredients don’t contribute to autism development (SABIN VACCINE INSTITUTE, 2017).
If a ten- year- long pool of erroneous data still influences parental decisions, such inoculation hesitancy sentiments can trickle down to less- developed nations where childhood disease (e.g., measles) outbreaks could have massive disastrous repercussions. Fortunately, many individuals realize the significance of group immunity when it comes to protecting weak or too- young babies yet to be inoculated. A recent policy change by the AAP (American Academy of Pediatrics) permits physicians to deny treatment to children if their parents refuse inoculations. Innumerable concerned parents have been voicing demands that anti- inoculation groups not put their children’s health at risk and that philosophical and religious immunization exemptions be put to an end. The science here is clear- cut: the evidential pool reveals no linkage between autism and vaccines, which have actually served as the greatest life- saving contemporary medical innovation. Hence, vaccine- related exemptions and hesitancy constitute a troublesome trend in America, which the research cannot export or encourage (SABIN VACCINE INSTITUTE, 2017).
3. Research Method – Explain/ describe one or two methods and how would you go about investigating this research? Explain in detail.
A retrospective cohort research design represents an epidemiologic observational research design wherein disease risk is compared in retrospect between unexposed and exposed clusters. Firstly, subjects of cohort researches don’t possess the outcome of interest. Choice of subject is on the basis of his/ her exposure status. Therefore, at baseline or during research commencement, the study will have both exposed and unexposed respondents. Subjects are subsequently followed over a certain period of time for evaluating for outcome- of- interest occurrence. During follow- up, the outcome will be developed by a few exposed subjects whereas the outcome of interest will be developed by a few unexposed ones. In such cohort researches, information is amassed from records. Hence, outcomes have previously emerged. Despite this, the fundamental research design essentially remains the same. Therefore, the researcher commences with variables like exposure at the baseline as well as follow- up stages, followed by measuring follow- up outcome. At times, the direction, whether retrospective or prospective, might not be clear. Both retrospective and prospective information on subjects may be analyzed (Setia, 2016).
A retrospective cohort research would be performed through adopting a large- scale American health plan- related administrative claims database, namely the Optum Research Database, which includes over 34 million persons per annum (commercially insured as well as Medicare recipients). The database encompasses de- identified proprietary health claims information from across the United States (36% South, 27% Northeast, 20% Midwest, and 16% West). Further, enrollees’ gender and age distribution resembles the American Census Bureau figures for Medicare as well as commercially insured groups. Commercially- insured index children with pharmacy as well as medical coverage will identified, including those enrolled continuously within the health plan between 0 - 5 years, at the very least. MMR shot receipt would be identified as having a CPT (Current Procedural Terminology) or ICD-9-CM that indicates individual components’ receipt (measles, rubella, and mumps) after 12 months of age. As the recommended first MMR immunization age is 12 - 15 months, and second dosage age is 4 - 6 years, relative risk would be gauged for comparing autism status among those receiving the first MMR shot at 2 years of age and the second shot at 5 years of age against children not inoculated at these ages (two dose relative risk at four years of age would encompass only those receiving dose II before turning 4) (Jain et al, 2015).
4. Sample – Explain/ describe the sample type that will be used to investigate and carry out this investigation/ research.
This technique constitutes a simple-random-sampling variation, thereby necessitating sampling frame availability. But, here, the entire population will be segregated into homogeneous subgroups or strata based on some demographic factor (for instance, age, sex, religion, education, diagnosis, socioeconomic status and so forth). This is followed by the researchers choosing random samples from diverse strata. The approach has the following advantages: (1) Researchers can acquire effect sizes from individual strata individually, as though it were a different research. Thus, disparities between groups become evident; and (2) Samples may be acquired from under- represented/ minority populations. If simple random sampling is adopted, minorities continue to be underrepresented in the study as the technique typically represents the overall target population. In this instance, researchers would do well to bank on stratified random sampling for obtaining appropriate samples from every stratum (Elfil & Negida, 2017).
The research utilizes three samples. Epidemiologic information on MMR- inoculated children born with a diagnosis of pervasive developmental disorder (post- MMR group) will be compared with information from a couple of prior pre- MMR clinical samples of ASD- diagnosed individuals. Assessment of all patients will be performed using the standardized ADI (Autism Diagnostic Interview), facilitating rigorous age comparison at first parent concern and regression rates across samples. Reliability would depend on parental concern age, developmental regression, and ADI scores. Moreover, epidemiologic surveys from parental as well as pediatric sources reveal information on bowel disorders and symptoms, and computerized records would be used to obtain immunization dates (Fombonne & Chakrabarti, 2001).
5. Data Collection – Explain/ describe where you will gather or get your information from?
After receiving ethical approval, affected children’s parents and two controls for every affected child (practice- matched and not matched and closest to the affected child’s age) will be surveyed. Surveys to autistic children’s parents will encompass an ASD screening questionnaire besides soliciting information on: date of autism symptom onset and date of earliest parental concern regarding potentially autism- related symptoms; the child’s educational status; parents’ beliefs and knowledge regarding ASD’s causes; and pervasive developmental condition- related family history. Further, this survey will, in specific, seek information on pervasive developmental conditions in the family, regression and genetic disorders, facilitating classification of affected children as those with and without regression. For controls as well as affected children, the survey will incorporate questions on: parents’ socioeconomic status; family size and birth order; immunization history; and child’s bowel disturbance history (Smeeth et al. 2001).
6. Protection of Human subjects – explain/ describe the use of inform consent, Anonymity, IRB-Institutional Review Board.
A key research- related ethical principle (that of informed consent) is: respondents of a study are well aware of participation- connected benefits and risks and voluntarily choose to participate. Except for available document review and unobtrusive observation within public locations, research participants ought to understand the procedure’s nature, what is expected of them, the research sponsor, confidentiality level offered, benefits and risks, their freedom to refuse participation, and their freedom to withdraw participation whenever they desire. Survey respondents will be offered a prepared consent form. Studies on children and other vulnerable population groups are especially responsible for protecting their human subjects (Buchanan, 2004). Informed consent was waived by the New England Institutional Review Board, which deemed the research exempt on account of its employment of extant de- identified information.
7. Summary
In this research, immunization of children with MMR might not be linked to increased ASD risk. The research has two related MMR vaccine-related goals: 1) Ascertaining whether autistic children will more likely receive the MMR shot before disease onset. 2) Examining whether any link exists between clinical disease onset and MMR vaccine timing.








References
Buchanan, E. A. (2004). Readings in virtual research ethics: Issues and controversies. Hershey, Pa: Information Science Publ.
Elfil, M., & Negida, A. (2017). Sampling methods in Clinical Research; an Educational Review. Emergency, 5(1), e52.
Fombonne, E., & Chakrabarti, S. (2001). No evidence for a new variant of measles-mumps-rubella–induced autism. Pediatrics, 108(4), e58-e58.
Jain, A., Marshall, J., Buikema, A., Bancroft, T., Kelly, J. P., & Newschaffer, C. J. (2015). Autism occurrence by MMR vaccine status among US children with older siblings with and without autism. Jama, 313(15), 1534-1540.
Mrozek-Budzyn, D., Kie?tyka, A., Majewska, R., & Augustyniak, M. (2013). Measles, mumps and rubella (MMR) vaccination has no effect on cognitive development in children–The results of the Polish prospective cohort study. Vaccine, 31(22), 2551-2557.
SABIN VACCINE INSTITUTE. (2017). Vaccines Don't Cause Autism. Retrieved July 6, 2018, from https://www.sabin.org/updates/blog/vaccines-dont-cause-autism-0
Setia, M. S. (2016). Methodology Series Module 1: Cohort Studies. Indian Journal of Dermatology, 61(1), 21–25. http://doi.org/10.4103/0019-5154.174011
Smeeth, L., Hall, A. J., Fombonne, E., Rodrigues, L. C., Huang, X., & Smith, P. G. (2001). A case-control study of autism and mumps-measles-rubella vaccination using the general practice research database: design and methodology. BMC public health, 1(1), 2.